Topical efficacy may be increased by using a higher concentration or occlusive dressing therapy.a (See Administration with Occlusive Dressing under Dosage and Administration.)

Response may vary from one topical corticosteroid preparation to another.a

Anti-inflammatory activity may vary considerably depending on the vehicle, drug concentration, site of application, disease, and individual patient.a

Cream, ointment, gel, lotion, shampoo, and foam (0.05% clobetasol propionate) are considered to have high-range potency.18788a

Not to be used in the treatment of rosacea1618808789 or perioral dermatitis.1808789 Topical corticosteroids generally should not be used in the treatment of acne61880 or as monotherapy in the treatment of widespread plaque psoriasis.80

Clobetasol Propionate Dosage and Administration

General

Consider location of the lesion and the condition being treated when choosing a dosage form.a

Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.a

Lotions are probably best for treatment of weeping eruptions, especially in areas subject to chafing (e.g., axilla, foot, groin).a Lotions, gels, and aerosols may be used on hairy areas, particularly the scalp.a

Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.ad

Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol).188a (See Hypothalamic-Pituitary-Adrenal Axis Suppresion and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.1 If such contact occurs, flush affected eye(s) with copious amounts of water.80818283

Do not apply to the face or intertriginous areas (e.g., axilla, groin).1878889

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.a

Apply cream, ointment, gel, lotion, or foam sparingly in a thin film and rub gently into affected area.1808889b

To apply foam, invert canister; dispense a small amount (up to a maximum of a golf-ball-sized dollop or 1 1/2 capfuls) of foam into the cap of the canister, onto cool surface (e.g., saucer), or directly on the lesion, taking care to avoid contact with the eyes.88 Foam will begin to melt immediately upon contact with warm skin; do not dispense directly onto hands (unless the hands are the affected area).88 If the canister seems warm to the touch or the foam seems runny, place the canister under cold running tap water.88 Using clean, dry fingertips, gently massage foam into the affected area; repeat until the entire affected area has been treated.88 Avoid exposure to flames or smoking during and immediately after application.88

After a favorable response is achieved, frequency of application may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.a

Administration with Occlusive Dressing

Manufacturers state that the cream, gel, ointment, or solution should not be used with occlusive dressings.1808789 However, when appropriate, occlusive dressings may be used as directed by a clinician to augment efficacy of lotion, shampoo, or foam preparations.88bc (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of the corticosteroid preparation; rub gently into the lesion; and apply another thin film.a Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.a

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.a For added moisture in dry lesions, apply the corticosteroid preparation and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.a

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.a

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of clobetasol proprionate are essential at each dressing change.a

Occlusive dressing usually is left in place for 12–24 hours and therapy is repeated as needed.a Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.a

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.a

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.a (See Occlusive Dressings under Cautions.)

Dosage

Available as clobetasol propionate; dosage expressed in terms of the salt.180878889bc

Intermittent maintenance therapy, such as administration of the drug once12 or twice weekly2021 for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.122021

Pediatric Patients

Administer the least amount of topical preparations that provides effective therapy.a (See Pediatric Use under Cautions.)

Corticosteroid-responsive Dermatoses

Topical

Children ≥12 years of age: Apply cream, ointment, gel, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.1808184878889

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.18789

Adults

Corticosteroid-responsive Dermatoses

Topical

Apply cream, ointment, gel, lotion, foam, or solution sparingly to affected area twice daily, preferably in the morning and evening.1808184878889b

Discontinue when control is achieved; if improvement does not occur within 2 weeks, consider reassessment of the diagnosis.18789

Emollient cream or lotion (applied to no more than 10% of body surface area) may be used for up to 4 consecutive weeks in the management of plaque psoriasis; however, the manufacturers state that additional benefits of extended treatment (i.e., >2 weeks) should be weighed against the risk of HPA-axis suppression.89b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Apply shampoo to scalp once daily.c Discontinue when control is achieved.c If improvement does not occur within 4 weeks, consider reassessment of the diagnosis and consider substituting a less potent topical corticosteroid preparation.c

Prescribing Limits

Pediatric Patients

Corticosteroid-responsive Dermatoses

Topical

Maximum 50 g of 0.05% cream, ointment, or gel per week for no more than 2 consecutive weeks.1878889

Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.88

Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.80

Adults

Corticosteroid-responsive Dermatoses

Topical

Maximum 50 g of 0.05% cream, ointment, gel, or lotion per week for no more than 2 consecutive weeks.1878889b

Maximum 1 1/2 capfuls of foam per application; maximum 50 g per week for no more than 2 consecutive weeks.88

Maximum 50 mL (50 g) of 0.05% solution per week for no more than 2 consecutive weeks.80

In patients with plaque psoriasis, maximum 50 g of 0.05% emollient cream, shampoo, or lotion per week for no more than 4 consecutive weeks.89b

In patients with psoriasis of the scalp, maximum 4 consecutive weeks of therapy with shampoo.c

Special Populations

Geriatric Patients

No dosage adjustments with cream, ointment, gel, or solution.1808789 Titrate dosage carefully when using foam, lotion, or shampoo; initiate therapy at the low end of the dosage range.88bc

Cautions for Clobetasol Propionate

Contraindications

Known hypersensitivity to clobetasol propionate, other corticosteroids, or any ingredient in the formulation.180878889

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.18789bc

Major Toxicities

Risk of Systemic Effects with Highly Active Preparations

Clobetasol propionate is a potent topical corticosteroid and can be absorbed in sufficient amounts to produce systemic effects, including HPA-axis suppression.1371112131718192026275655596162647680878889bc (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

General Precautions

Hypothalamic-Pituitary-Adrenal Axis Suppression.

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.137111213171819202627465557596162647680878889bc HPA-axis suppression has occurred following topical dosages as low as 2 g of the 0.05% ointment or cream (1 mg of clobetasol propionate total) or 7 g of the 0.05% foam (3.5 mg of clobetasol propionate total) daily.17688

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation, morning plasma cortisol, urinary free cortisol), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.180878889bc

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.1a

Systemic Effects

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.a

Risk of adverse systemic effects increases with use of a high-potency topical corticosteroid, especially if applied to large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.a

Infants and children may be more susceptible to adverse systemic effects.878889d (See Pediatric Use under Cautions.)

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;a these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.a Do not apply to the face or intertriginous areas.1878889

Skin Infections

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.1878889bc If infection does not respond promptly, discontinue topical corticosteroid therapy until the infection has been controlled.1878889bc

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.ad In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.ad

Do not use occlusive dressings in patients with primary skin infection.d

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin);a however, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.a

Occlusive Dressings

Certain topical clobetasol propionate preparations (cream, gel, ointment, solution) should not be used with occlusive dressings.1808789

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.188a (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.188abc (See Local Effects under Cautions.)

Specific Populations

Pregnancy

Lactation

Not known whether topical clobetasol is distributed into milk.180878889bc Caution advised if topical clobetasol is used.180878889bc

Pediatric Use

Use of clobetasol propionate cream, ointment, solution, foam, or gel not recommended in children <12 years of age.1808788

Use of clobetasol propionate lotion or shampoo not recommended in children <18 years of age.bc

Use of clobetasol propionate emollient cream not recommended in children <12 years of age; use beyond 2 consecutive weeks has not been evaluated in children <16 years of age.89

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio,180878889bc especially when topical corticosteroids are applied to >20% of body surface area.a The risk of adrenal suppression appears to increase with decreasing age.a (See Systemic Effects under Cautions.)

Striae have been reported in children treated inappropriately with topical corticosteroids.1878889abc

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic effect; chronic topical corticosteroid therapy may interfere with growth and development.d

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether safety and efficacy of clobetasol propionate cream, ointment, gel, foam, lotion, or solution in geriatric patients differ from safety and efficacy in younger adults.180878889bc

Advice to Patients

Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.180878889abc (See Topical Administration under Dosage and Administration.)

Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.180878889ac

Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.180878889b

Importance of patients informing clinician that they are receiving topical clobetasol propionate therapy, if surgery is contemplated.8789bc

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.180878889bc

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.180878889bc

Importance of informing patients of other important precautionary information.180878889bc (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

84. Lassus A. Local treatment of psoriasis of the scalp with clobetasol propionate in alcoholic solution: a comparison of once and twice a day application. Curr Med Res Opin. 1976; 4:214-7. [PubMed 949901]